Kornimate/medical-research-clean huggingface dataset:
phase 1/2 study of velcade® in combination with other drugs to treat previously untreated multiple myeloma patients

Conditions: Multiple Myeloma

Summary: the purpose of this phase 1/2 study is to evaluate the efficacy and safety of treatment with velcade, dexamethasone, and revlimid® (vdr) as well as velcade, dexamethasone, cyclophosphamide, and revlimid (vdcr) in patients with multiple myeloma who have received no prior treatment. this study will evaluate whether the addition of revlimid to velcade and dexamethasone will increase the complete response (cr)/ very good partial response (vgpr) rate.


Eligibility criteria:
inclusion criteria: * voluntary written informed consent * male or female subject 18 years of age or older * a karnofsky performance status score of ≥50% (eastern cooperative oncology group performance status score ≤2) * subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage * diagnosed multiple myeloma * subjects must have measurable disease requiring systemic therapy * subjects must not have been treated previously with any systemic therapy for multiple myeloma * two weeks must have elapsed since the date of the last radiotherapy treatment * women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 to 14 days prior to therapy and repeated within 24 hours before starting study drug. they must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of revlimid treatment. women must also agree to ongoing pregnancy testing * men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential * all subjects must agree to comply with the requirements of the revassistsm program exclusion criteria: * history of allergy to any of the study medications, their analogues, or excipients in the various formulations * ≥grade 2 peripheral neuropathy on clinical examination * myocardial infarction within 6 months prior to enrollment or new york heart association class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities. * female subject who is pregnant or breast-feeding * clinically relevant active infection or serious comorbid medical conditions * any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study. this includes but is not limited to serious medical or psychiatric illness likely to interfere with participation in this clinical study * active prior malignancy diagnosed or treated within the last 3 years

Keywords: treatment for patients with multiple myeloma who have received no prior treatment
sex differences in early brain development; brain development in turner syndrome

Conditions: Turner Syndrome

Summary: relative risk for many psychiatric disorders differs dramatically in males and females. early-onset disorders, such as autism, occur more often in males; other conditions, such as schizophrenia, occur at similar rates in males and females, but the sexes differ in expression. it has been hypothesized that the prevalence and expression of these disorders is related to sex differences in brain development. x-chromosome effects and early exposure to gonadal hormones are strong candidates for a causal role. the aims of the research are (1) to characterize sex differences in brain development from birth to age 2; (2) to test whether brain development is altered in infants with turner syndrome, a well-defined genetic disorder resulting from the partial or complete loss of one of the sex chromosomes. to address aim 1, high resolution mri, including diffusion tensor imaging (dti), will be used to characterize sex differences in brain development from birth to age 2 in a longitudinal cohort of 250 children. to address aim 2, high resolution mri, including dti, will be used to compare brain development in 70 infants with turner syndrome (x monosomy) to matched controls from aim 1. the investigators hypothesize that sex differences in gray and white matter development and in white matter maturation as assessed by dti will be present during the first 2 years of life and that children with ts will exhibit abnormal gray and white matter development in the neonatal period.


Eligibility criteria:
inclusion criteria: * for controls a child must have a normal ultrasound at the 18 week prenatal visit and the absence of major medical or psychiatric conditions in the mother. * children with turner syndrome must have diagnosis confirmed by genetic testing. exclusion criteria: * for controls - major medical or psychiatric conditions in the mother and major medical problems or congenital conditions in the child. * for turner children - the study is open to all ts karyotypes except those with y chromosome material. * for both groups children with conditions that preclude participating in an mri scan ( i.e. metal in the body)
covid-19 and icu-acquired mdr bacteria

Conditions: Sars-CoV2; Critical Illness

Summary: this multicenter before-after study aimed to determine the impact of infection related to sars-cov-2 on the incidence of icu-acquired multidrug resistant (mdr) bacteria.

multicenter observational before-after study, aiming to determine the impact of infection related to sars-cov-2 on the incidence of icu-acquired colonization and infection related to mdr bacteria.

Eligibility criteria:
inclusion criteria: * expected icu stay \> 48 hours * rectal and nasal bmr screening performed \< 48 hours after admission to icu exclusion criteria: * patients aged \< 18 years refusal to take part in the study icu-stay \< 48 hours at least a second rectal and nasal bmr screening was not performed prior to icu discharge (a posteriori exclusion criterion).

Keywords: covid-19 critically ill patients multidrug-resistant bacteria infection colonization
evaluation of safety of a vaccine against cervical cancer in healthy korean females

Conditions: Infections, Papillomavirus

Summary: this post marketing surveillance (pms) will collect safety data on the use of gsk biologicals' human papillomavirus (hpv) vaccine in the local target population of females as per the regulations of the korean food and drugs administration (kfda).


Eligibility criteria:
inclusion criteria: * female subjects aged between and including, 10 to 25 years at the time of the first vaccination. * subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits etc) should be enrolled in the pms. * written informed consent obtained from the subject or the subjects' parent/ guardian. * subjects of childbearing potential must not be pregnant. absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement. * subjects with no contraindication according to the local approved prescribing information. * no previous administration of an hpv vaccine other than cervarix®. * no previous administration of more than two doses of cervarix®. * no planned administration of an hpv vaccine other than cervarix® during the pms

Keywords: post-marketing surveillance human papillomavirus korea safety prescribing information
a dose finding study to evaluate safety, drug interaction, tumor markers of axitinib in combination with mk-3475 in adult patients with previously untreated advanced renal cell cancer

Conditions: Renal Cell Carcinoma

Summary: despite substantial improvements of patients outcome in advanced rcc, durable and complete response is uncommon. the majority of patients eventually develop resistance and exhibit disease progression. combining a pd-1 inhibitor, which has shown single-agent efficacy with axitinib may provide additional clinical benefit compared to axitinib alone.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced rcc with predominantly clear-cell subtype with primary tumor resected * at least one measureable lesion as defined by response evaluation criteria in solid tumors (recist) version 1.1. * eastern cooperative oncology group performance status 0 or 1 * controlled hypertension exclusion criteria: * prior treatment with systemic therapy for advanced rcc * prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred during or within 12 months after the last dose of treatment * prior treatment with any agent specifically targeting t-cell co-stimulation or checkpoint pathways * active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis * diagnosis of any non-rcc malignancy occurring within 2 years prior to the date of randomization except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with no plans for treatment intervention * in past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack * in past 6 months: deep vein thrombosis or pulmonary embolism

Keywords: axitinib and mk-3475 patients with advanced renal cell cancer.
safety and effectiveness study of rf ablation of uterine fibroids to reduce menstrual bleeding: the fibroid ablation study

Conditions: Leiomyoma; Uterine Fibroids; Menorrhagia

Summary: the primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.


Eligibility criteria:
inclusion criteria: * pre-menopausal * regular, consistent menstrual cycles * serum progesterone \> 6 ng/ml (19 nmol/l) * 2 months history of pblac score of 150-500 * maximum of 4 type i, type ii, or intramural fibroids * patient is at low risk for cervical cancer * hemoglobin \> 6 g/dl * not at risk for pregnancy * no desire for future fertility * willing and able to complete the follow-up requirements outlined in the study design section of the protocol * willing to sign a consent form exclusion criteria: * subserosal fibroids. * any fibroid that obstructs access to the endometrial cavity * fsh \> 20 iu/l * pregnancy * evidence of disorders of hemostasis * use of gnrh agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen * serms/sprms within the last 6 months * current use of any iud or use of mirena ius within the last 3 months * gynecological malignancy or hyperplasia * known/suspected abdominal/pelvic cancer * active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease) * adenomyosis * previous surgical or ablative treatment for fibroids or menorrhagia * previous uterine artery embolization or occlusion * patient on anti-coagulation therapy * needing emergency surgery to treat fibroid symptoms * concomitant intrauterine polyps. * major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data * contraindication to mri * allergy to contrast media * mild renal insufficiency or worse * known renal disease * uncontrolled hypertension lasting 2 years or more * diabetes * uterine size \> 10 weeks or 10 cm from ectocervix to fundus.

Keywords: uterine fibroid rf ablation intrauterine ultrasound vizablate
catheters dysfunction rate after instillation of ethanol 60% lock solution in tunneled silicone catheter of chronic hemodialysis patients

Conditions: End Stage Renal Failure, Hemodialysis

Summary: the primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis. the catheters dysfunction rate is the primary outcome. the dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter. as a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)


Eligibility criteria:
inclusion criteria: * patients of both genders, over 18 years, * chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days, * written informed consent * social security exclusion criteria: * antibiotic therapy during selection phase, * partial or complete catheter occlusion during selection phase, * venous pressure at dialysis connection \> 300 mmhg, * known allergy to ethanol, * patient involved in any other clinical trial or in the exclusion period * severe co-morbidity * acute or chronic infectious disease * evolutive neoplasia, * hiv, hcv positive serology at inclusion, * scheduled surgery

Keywords: ethanol, lock solution, infection
kindness interventions in enhancing well-being in breast cancer survivors

Conditions: Cancer Survivor; Stage 0 Breast Cancer AJCC v6 and v7; Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7

Summary: emerging evidence suggests that both extending kindness towards others and self-kindness practices may have beneficial effects on well-being. this randomized pilot clinical trial will investigate the efficacy of two kindness interventions -acts of kindness (to self or to other) and loving-kindness meditation- for use with early-stage breast cancer survivors.

primary objectives: i. to refine two interventions - loving kindness and acts of kindness- for use with breast cancer survivors using an online platform. ii. to determine the feasibility and preliminary efficacy of these interventions on positive affect, depressive symptoms, and other aspects of well-being among women with breast cancer. outline: participants are randomized to 1 of 4 groups. group i (acts of kindness to others): participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires. group ii (acts of kindness to self): participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires. group iii (self-kindness meditation): participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires. group iv (control): participants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. at the end of the week, participants report on their activities and complete several online questionnaires.

Eligibility criteria:
inclusion criteria: * women previously diagnosed with stage 0-iiia breast cancer * have completed treatment with surgery, radiation, and/or chemotherapy * have not had a cancer recurrence * have access to the internet and an active email account
epidemiology and risk factors of uterine fibroids in china

Conditions: Uterine Fibroid

Summary: uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer, which had a certain rate of malignancy, but it is rare. the prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. the prevalence of fibroids has been historically underestimated by epidemiologic studies which focused mainly on symptomatic women, leaving behind a large population of asymptomatic women and women who underreport their symptoms. what investigators don't know was which women who have fibroids will develop clinical symptoms and which women who have an operation of myomectomy will relapse. the purpose of this study is to investigate the prevalence, incidence and risk factors for the development of uterine fibroids in chinese women.


Eligibility criteria:
inclusion criteria: * current place of residence≥ 6 months; * no serious mental illness or mental abnormality; * those who agree to participate in this survey and cooperate in completing the questionnaire. exclusion criteria: -
systemic markers of inflammation: 9- and 12-month follow-up post non-surgical periodontal therapy

Conditions: SRP; Minocycline HCl Microspheres; Biomarkers

Summary: the primary goal of this study is to determine the amount of three systemic markers of inflammation: 1) hemoglobin a1c (hgb a1c, 2) high sensitivity c-reactive protein (hscrp), and 3) haptoglobin (hp) at 9 and 12 month follow-up post scaling and rootplaning (srp) with and without minocycline hcl microspheres, 1 mg.

participants from a randomized controlled clinical trial approved by the university of minnesota (umn) institutional review board (irb) study00004876 and registered on clinicaltrials.gov (nct03762915) identifying the effects of srp with and without minocycline hcl microspheres, 1 mg on periodontal pathogens and systemic inflammatory markers in the blood serum will be invited to participate in this 9 and 12 month follow-up study.

Eligibility criteria:
inclusion criteria: - participated in interventional phase of the trial study00004876 exclusion criteria: * unable to comply with study protocol * cigarette use within the last year * ≥2 weeks of antibiotic use in the past three months or antibiotic use in the last six weeks. * pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported) * diagnosed cardiac conditions (cardiovascular disease (cvd) or atherosclerotic vascular disease (asvd) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization * have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes hba1c \> 7, hiv, etc.) * any medication that may impact periodontal conditions (phenytoin, calciumantagonists, cyclosporin, warfarin, or nsaids)
evaluation of the efficiacy of mecobalamine in the treatment of long-term pain in women diagnosed with fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia causes long term pain where mostly women are affected. it is not entirely clear how vitamin b12 affects the human pain system, there are however many primary studies that indicate different interesting approaches. considering that the receptor of nmda is involved in both long-term pain and vitamin b12 deficiency its of most importance to evaluate whether vitamin b12 decreases the pain sensitivity and the experience of pain i.e hyperalgesia and allodynia, at persons with fibromyalgia.the aim of this study is therefore to evaluate the effect of mecobalamin (vitamin b12), and describe lived experiences of pain, health, suffering and well-being in women with diagnosed fibromyalgia.


Eligibility criteria:
inclusion criteria: * women aged 20-70 years * swedish-speaking * diagnosis of fibromyalgia * safe method of contraception * cobalamin / p (vitamin b12) should be \>250 pmol/l \< 800 pmol/l * given consent to participate. exclusion criteria: * previous treatment with b12 * known hypersensitivity to the active substance mecobalamin or an additive * vegan as veganism can lead to b12 deficiency * neuroleptics * known heart, kidney or liver disease * reynaud's phenomenon (white fingers) * known neuropathy (impaired sensation) * breastfeeding * pregnancy or plan pregnancy

Keywords: fibromyalgia, chronic pain, mekobalamin, randomized controlled trial vitaminb12
ds vs sips-bariatric surgery comparasion

Conditions: Bariatric Surgery Candidate

Summary: the aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (sips) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (ds) operation. please note, this study does not provide a stipend or coverage for surgery.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 40 to 65 * agree to not use weight loss medications for the length of the study * compliance with standards of surgical program exclusion criteria: * patients with a history of previous bariatric surgery except for patients who have had a previous gastric sleeve * previous complex abdominal surgery * poorly controlled medical or psychiatric disease

Keywords: bariatric duodenal switch ds weight loss surgery sips single anastomosis
the effect of simple clinical maneuver on shoulder and abdominal pain a laparascopic gynecological surgery:a prospective randomised trial

Conditions: Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic Surgery

Summary: the investigators think that a simple maneuver at laparascopic surgery to reduce the postoperative pain.


Eligibility criteria:
inclusion criteria: 1. females aged 15-65 years, 2. american society of anesthesiologists (asa) physical status classification i-iii 3. no previous laparotomy(major abdominal surgery). 4. need a laparascopic surgery exclusion criteria: 1. required hospitalization after the laparoscopic surgery, 2. the procedure required conversion to laparotomy 3. if a 48-hour follow-up was not feasible
evaluating the impact of including virtual dietary education within an electronic irritable bowel syndrome pathway

Conditions: IBS - Irritable Bowel Syndrome

Summary: irritable bowel syndrome is a functional bowel disorder that affects many canadians. the syndrome involves abdominal pain and change in frequency or form of bowel movements, and these symptoms can lead to a decreased quality of life for patients. primary care physicians are dissatisfied with current referral processes, and patients may wait a long time to receive the correct diagnosis. diet is known to exacerbate symptoms of ibs. in canada, accessing dietary treatment for ibs is a challenge due to lack of resources. some patients lack access to dietary interventions, and others are given advice that is not evidenced based. use of ehealth technology, such as virtual education delivered by a dietician, may allow for more widespread access to dietary interventions for ibs. virtual education can include one on one dietary education, online group-based education, and the use of apps. currently, there is a gap in knowledge whether dietary intervention for ibs, delivered virtually by a dietician, is effective in treating ibs.


Eligibility criteria:
inclusion criteria: * recurrent abdominal pain on average at least 1 day/ week in the last 3 months associated with two or more of the following criteria: related to defecation, or association with a change in frequency of stool or associated with a change in form (appearance) of stool * willingness to change diet * access to a device for accessing virtual dietary education exclusion criteria: * new onset symptoms within past year in age 50 and above * rectal bleeding * inflammatory bowel disease * unexplained recent weight loss * gastrointestinal surgery with removal of gallbladder or segments of the bowel * having an eating disorder